FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.
CDRH also regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.
Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III.
- Class I devices are exempt from Premarket Notification 510(k)
- Class II devices require Premarket Notification 510(k)
- Class III devices require Premarket Approval.
Source: FDA
Posted by abhishekkatiyar 
